Urine HPV testing for cervical cancer screening in HIV-infected women in South Africa

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of urine samples for screening cervical cancer in women living with HIV in South Africa. It aims to validate high-risk HPV testing on urine specimens and compare its sensitivity and specificity to traditional self- or clinician-collected samples. Given the high risk of cervical cancer among HIV-infected women, this research seeks to provide a more accessible and scalable screening method in low-resource settings. The study will involve participants aged 25 and older who can provide informed consent and meet specific health criteria.

Why it matters

Who can join: the full rules

Inclusion Criteria:

In order to participate in this study a subject must meet all of the eligibility criteria outlined below.

1. Confirmed HIV-1 infection
2. Age 25 years and older.
3. Be willing and able to provide written informed consent.

Exclusion Criteria:

1. Pregnant or intend to become pregnant within 90 days of enrollment
2. Have been screened for cervical cancer within the preceding year (365 days)
3. Have an active sexually transmitted infection (STI; women may participate once treated)
4. Have a surgically absent cervix
5. Have a history of cervical cancer
6. have been vaccinated against HPV.

Where it's running

• Clinical HIV Research Unit Temba Lethu Wing Helen Joseph Hospital
  Westdene, Johannesburg, South Africa Recruiting

Study contacts

• Principal investigator: Carla Chibwesha, MD, MSc — Division of Global Women's Health Department of Obstetrics and Gynecology, UNC Chapel Hill, NC
• Study coordinator: Cheryl Hendrickson
• Email: cheryl_hendrickson@med.unc.edu
• Phone: 919-843-2541

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Cervical screening and care options for women living with HIV who test positive for high-risk HPV

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• Hydrogel spacer to protect the rectum during cervical cancer radiotherapy

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.